Clinical Trials in the USA / NCT07723833
Recruiting
Phase 1
A Study to Investigate the Relative Bioavailability and Safety of Different Oral Formulations of Elecoglipron in Healthy Participants
NCT07723833 · tracked via the Priya Life Science USA tracker
Condition(s) studied
Healthy Participants
Investigational drug(s) / intervention(s)
Elecoglipron Reference Formulation Dose AElecoglipron Test formulation 1 Dose AElecoglipron Reference Formulation Dose BElecoglipron Test formulation 1 Dose BElecoglipron Test formulation 2 Dose AElecoglipron Test formulation 2 Dose B
Elecoglipron Reference Formulation Dose A: Elecoglipron tablets will be administered orally.
Elecoglipron Test formulation 1 Dose A: Elecoglipron tablets will be administered orally.
Elecoglipron Reference Formulation Dose B: Elecoglipron tablets will be administered orally.
Elecoglipron Test formulation 1 Dose B: Elecoglipron tablets will be administered orally.
Elecoglipron Test formulation 2 Dose A: Elecoglipron tablets will be administered orally.
Elecoglipron Test formulation 2 Dose B: Elecoglipron tablets will be administered orally.
Study summary
The purpose of this study is to measure the pharmacokinetics (PK-how the body processes the study drug) of elecoglipron in healthy participants when taken by mouth as different formulations.
Eligibility
Inclusion Criteria:
* Healthy participants with suitable veins for cannulation or repeated venipuncture.
* All females must have a negative pregnancy test at the Screening Visit and on admission to the Clinical Unit.
* Females of childbearing potential must not be lactating and if heterosexually active, must agree to use an approved method of highly effective contraception.
* Females of non-childbearing potential must be confirmed at screening visit as postmenopausal or have documentation of irreversible surgical sterilization.
* Sexually active fertile male participants with partners of childbearing potential must adhere to the study specific contraception methods.
* Have a body mass index between 18.5 and 30 kg/m2 inclusive and weigh at least 50 kg.
Exclusion Criteria:
* History of any clinically important disease or disorder.
* History of acute pancreatitis.
* History or presence of gastrointestinal (GI) or any other condition known to interfere with absorption, distribution, metabolism, or excretion of drugs.
* Clinically significant inflammatory bowel disease, gastroparesis, severe disease, or surgery affecting the upper GI tract.
* Any clinically important illness, medical/surgical procedure, or trauma.
* Participants who have previously received elecoglipron within the last 3 months.
Primary outcome measure(s)
- Maximum observed drug concentration (Cmax) — At pre-defined intervals from Day 1 to Day 15
To evaluate the PK of different formulations of elecoglipron following single oral administration in healthy participants. - Area under concentration-curve from time 0 to the last quantifiable concentration (AUClast) — At pre-defined intervals from Day 1 to Day 15
To evaluate the PK of different formulations of elecoglipron following single oral administration in healthy participants. - Area under concentration-time curve from time 0 to infinity (AUCinf) — At pre-defined intervals from Day 1 to Day 15
To evaluate the PK of different formulations of elecoglipron following single oral administration in healthy participants. - Time to reach maximum observed concentration (tmax) — At pre-defined intervals from Day 1 to Day 15
To evaluate the PK of different formulations of elecoglipron following single oral administration in healthy participants. - Terminal elimination rate constant (λz) — At pre-defined intervals from Day 1 to Day 15
To evaluate the PK of different formulations of elecoglipron following single oral administration in healthy participants. - Terminal elimination half-life (t1/2λz) — At pre-defined intervals from Day 1 to Day 15
To evaluate the PK of different formulations of elecoglipron following single oral administration in healthy participants. - Apparent total body clearance (CL/F) — At pre-defined intervals from Day 1 to Day 15
To evaluate the PK of different formulations of elecoglipron following single oral administration in healthy participants. - Apparent volume of distribution based on the terminal phase (Vz/F) — At pre-defined intervals from Day 1 to Day 15
To evaluate the PK of different formulations of elecoglipron following single oral administration in healthy participants. - Ratio of elecoglipron (test formulation) to elecoglipron (reference formulation) based on AUCinf (R AUCinf) — At pre-defined intervals from Day 1 to Day 15
To evaluate the PK of different formulations of elecoglipron following single oral administration in healthy participants. - Ratio of elecoglipron (test formulation) to elecoglipron (reference formulation) based on AUClast (R AUClast) — At pre-defined intervals from Day 1 to Day 15
To evaluate the PK of different formulations of elecoglipron following single oral administration in healthy participants. - Ratio of elecoglipron (test formulation) to elecoglipron (reference formulation) based on Cmax (R Cmax) — At pre-defined intervals from Day 1 to Day 15
To evaluate the PK of different formulations of elecoglipron following single oral administration in healthy participants.
Trial sites (2)
| Facility | City | Region | Status |
|---|---|---|---|
| Research Site | Glendale | California | Recruiting |
| Research Site | Brooklyn | Maryland | Recruiting |
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Official registry record
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT07723833 on ClinicalTrials.gov ↗ ← All trials in the USA